the study of ammoxetine hydrochloride enteric-coated tablets in subjects with depression

Conditions: Major Depressive Disorder (MDD)

Summary: the purpose of this study is to evaluate the efficacy and safety of ammoxetine hydrochloride enteric-coated tablets in subjects with depression.

in this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of different doses of ammoxetine hydrochloride enteric coated tablets in the treatment of depression.

Eligibility criteria:
inclusion criteria: 1. subjects aged 18 and 65 years (inclusive), no gender limitation; 2. subject has recurrent major depressive disorder (mdd) as the primary diagnosis according to diagnostic and statistical manual of mental disorders (dsm-5, 5th edition), single episode or recurrent episodes (dsm-iv-tr criteria, classification code 296.2/296.3), without psychotic symptoms; 3. subjects with a montgomery-asberg depression rating scale (madrs) score ≥ 26 at screening and baseline; 4. subjects with clinical global impression scale disease severity cgi-s severity score ≥ 4 at screening and baseline; 5. a score of ≥2 on the first item (depressed mood) of the hamd-17 scale at the screening and baseline; 6. male or female with fertility must agree to use effective contraceptive method during the study and within 1 month after the end of the trial; 7. be able to read and understand the content of the informed consent and voluntarily sign the informed consent. exclusion criteria: 1. subjects with ≥ 25% reduction in madrs score in the baseline period compared to the screening period; 2. subjects meet dsm-5 diagnostic criteria for other mental disorders (schizophrenia spectrum and other psychiatric disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders, etc.); 3. subjects are diagnosed as dsm-5 drug use disorder; 4. refractory depression (subjects who had previously used two different mechanisms of antidepressants and failed after receiving adequate treatment (at least 8 weeks); 5. organic mental disorders, such as depression caused by hypothyroidism; 6. depression caused by psychoactive substances or non-addictive substances; 7. subjects with other diseases or other types of mental disorders with depressive symptoms; 8. subjects assessed by the columbia suicide severity rating scale (c-ssrs) and those judged by the investigator to be at risk for suicide, or to have engaged in suicidal behavior within 6 months prior to screening; 9. allergic constitution (e.g. allergic to two or more drugs or to serotonin norepinephrine reuptake inhibitors (snris)); 10. previous history of malignant tumor; 11. previous history of elevated intraocular pressure or narrow angle glaucoma; 12. subjects suffered from other serious physical diseases, such as uncontrolled hypertension or unstable cardiovascular disease, serious liver disease, kidney disease, blood disease, endocrine disease, neurological disease, etc; 13. subjects with diseases that interfere with the absorption of oral medications, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc; 14. subjects who have used drugs or foods that alter the activity of liver enzymes (cyp2c19 and cyp3a4) such as dexamethasone, rifampicin, omeprazole, etc., within 4 weeks prior to randomization; 15. 12-lead ecg system showed degree ⅱ or ш atrioventricular block, long qt syndrome or qtc \> 450 ms (male) / 460 ms (female) at screening; 16. subjects discontinued use of a combination of drugs that prolong the qt interval prior to randomization, or drugs that can cause prolongation of the qt and may induce tdp for less than 5 half-lives of the drugs; 17. in screening period, subjects with alt or ast 2 times higher than the upper limit of laboratory normal value; and abnormalities in 2 or more of the 5 indicators of thyroid function (tsh, ft3, ft4, tt3 or tt4 0.9 times below the lower limit of normal value or 1.1 times above the upper limit of normal value); 18. subjects have used monoamine oxidase inhibitors within 2 weeks before randomization; 19. subjects discontinuing antipsychotics, antidepressants or mood stabilizers for less than 5 half-lives of the drug before randomization; 20. subjects who are using long half-life drugs (such as fluoxetine, long-acting antipsychotics, etc.); 21. subjects who have received electroconvulsive therapy (ect), systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavior therapy, etc.), transcranial magnetic stimulation (tms), vagus nerve stimulation (vns), phototherapy, etc. within 3 months before screening, or subjects who, in the judgment of the investigator, are currently in need of such treatment; 22. female subjects who are breastfeeding or have a positive pregnancy test during the screening period or during the study; 23. alcohol or drug dependence within 3 months before screening; 24. subjects who have participated in other clinical trials within 3 months before screening and are taking the test drug; 25. subjects who, in the opinion of the investigator, have any other condition that makes them unsuitable for participation in this trial.

Keywords: mdd